MAUDE Adverse Event Report: MEDACTA SWITZERLAND STEM COLLARED HA COATED STD STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.18.235
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 166469: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 2022-01-22.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on (b)(6) 2018: hip revision surgery occurred 9 months after primary cementless total hip arthroplasty in a (b)(6) kg patient.Aseptic loosening is a possible, literature described adverse event after cementless tha and causes are often unknown.In this case, the stem failed to find initial stability, for reasons that remain unknown.
Event or Problem Description
Revision surgery performed after 9 months from primary due to stem loosening.
Additional Manufacturer Narrative
Visual inspection performed by r&d product manager on 28 march 2018 the collared stem appeared with a coating still present in the proximal area of the shaft, while some bone tissue were found in the macrostructures, especially in the distal part.A small groove were noticed on the neck, just under the taper.The ceramic ball head had some signs, probably occurred during the extraction.From the received parts it was not possible to determine the root cause of the event.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA SWITZERLAND; gewerbestrasse 3; frauenfeld, switzerland 8500 ; SZ 8500
• MDR Report Key: 7273175
• Report Number: 3005180920-2018-00045
• Device Sequence Number: 10798807
• Product Code: LZO
• UDI-Device Identifier: 07630030804601
• UDI-Public: 07630030804601
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: 01.18.235
• Device Lot Number: 166469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR